Vancomycin and adults - PSC?

General
1

Hello everyone,
In recent weeks I’ve been diagnosed with recurrent PSC after 6-1/2 years post-liver transplant with no real issues. On top of the recurrent PSC I’m dealing with scar tissue at the anastomosis of my transplant closing up the bile duct, thus multiple surgeries using interventional radiology to balloon dilate it back open.

My question today is in regards to adult use of vancomycin. I would appreciate any information you can give me on your experience as an adult with Vanco, what brands work best, what dosages have been efficient in keeping your LFTs under control, etc. I’m particularly interested in adult use, not pediatric use who then have become adults later in life and are still using it. There’s not a lot of information out there on adult use, so I need as much information as possible so I can present it to my transplant team at Duke Medical. Thanks so much in advance.

P.S. I just remembered this post dealing with Adults and Vanco which I am rereading now. I still would appreciate any input you might have. Thanks.

Mark
PSC 2011, 2021 / Transplant 2015

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Mark,
Sorry to hear this. Your story has been the one that has kept me optimistic since my son’s diagnosis.
He was diagnosed in 2016 (at age 21) and has been on Vanco since October 2017. Its been a miracle drug for him. Although he never had any PSC symptoms (diagnosed after a routine blood test with very high enzyme levels), within 1 month of starting Vanco all levels normalized.
His original MRP and liver biopsy showed moderate scaring. His latest MRP (in 2020) showed no progression.
Since my son is unable to swallow pills, he takes liquid Firvanq- 500 mg/3 x per day. His doctor has never reduced the dosage and my son has no issues. He goes to the dentist for a cleaning every 3 months.
I urge you to give Vanco a try ASAP. The liquid form, from what I have read here, seems to be the one sure-fire method.

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Sorry to hear that Mark. I got rPSC after 2 years, fretted for two hours till I read about Vancomycin (2014) , and felt much better that there was something ‘I could do’. I have had stellar success following Cox/Stanford experience (the 500 mg 3 times per day) weaned down to 500 per day (250 twice a day) after a year. All LFT’s normalized which according to at least one of the guru doc’s in Vanco/PSC research is the experience in 2/3 of patients (and the 1/3 could be advanced disease and other factors). So good odds sir! If you haven’t already, re-read every Vanco/adult vanco post on this site - lots of information there (here!). I take IV powder of various brands (orally administered of course) , others can weigh in with there successes. I’m back to normal, I almost feel like an imposter but my Doc’s can’t take back the diagnosis nor explain the remission - without acknowleding cause and effect which is strangely a contraversy. Take hard copies of the literature with you to your doctor, make your case, leave them with the papers to study - ‘no’ is not an option.

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Dear Mark,

I too am so deeply sorry to read this.

As I think you know I’ve been on Vancomycin for almost four years now.

My liver enzymes continue to fluctuate and I continue as well to struggle with feeling quite unwell much of the time. Nonetheless, my UC has been far improved, and my liver enzymes, although only normalized a couple times in the last four years, remain far lower than they were at diagnosis almost thirty years ago now.

I’ve gone back and forth between ANI and FirVanQ. Sometimes based on my travel plans - it was impossible to bring a liquid which requires refrigeration camping for three weeks in Iceland, sailing, island Maine camping, etc., - as even though I continue to feel pretty much awful 24/7/365, I am determined to live my life to the fullest with a relatively new sweetheart who, as I do, loves to explore wild places.

It’s difficult to access how differently each one has effected me, and in the end I would have to say they have been comparable. As of tomorrow I am switching back to FirVanQ as an incredible resource my local gastroenterologist connected me with, CPhT Specialty Pharmacy Liaison, was able to get my pharmaceutical insurance to cover the liquid (as she previously did for the ANI, after my insurance refused), and my liver enzymes were at their high as of last week.

I’ve never tried all the other brands, nor any liquids compounded by the hospitals where my liver specialist or my gastroeonerolgist works and offered to me as they could not assure me the base for their compound would come from the same source month to month. Also, from everything I’ve read these past years, ANI and FirVanQ are the way to go.

I’ve fluctuated with the dose and am now down to 250mg three times a day.

Let me know if you have any other questions.

I’m thinking of you,

Susan
PS I turned 66 last July so most certainly an adult.

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Mark, sorry to hear about the dx.

I began oral vancomycin treatment at 31, around the time I was undergoing the transplant listing process for recurrent cholangitis. I’ve been on the treatment for 8 years and it has kept me asymptomatic with normal LFTs.

I started taking 1500mg/day and weaned down slowly to 500mg/day. Some people get away with low doses while others need high doses to keep everything in the normal range. The Stanford protocol (I believe also used in the current Mayo trial?) seems to have met the most success. This is for adults to start at 1500mg/day and to wean down slowly after a year if everything is normal or to increase dose incrementally (topping out at 3000mg/day) if LFTs and symptoms don’t fully normalize after a couple months.

Some people find differences in efficacy between brands of pills. This increasingly looks like it is an issue with the gel caps of certain generics (some dissolve more slowly than others). The pills that seem to work the best are Ani pharma name brand Vancocin and the Ani authorized generic (reboxed Vancocin). Many pharmacies can special order the Ani generic if asked. An alternative is IV vancomycin taken orally (typically this is a liquid). This is an option if insurance won’t cover as it is significantly less expensive than the pills. It also doesn’t have the gel cap issue. Drinking the liquid can cause extra plaque buildup and non-permanent staining on teeth. It is also less convenient to deal with day to day.

I don’t have my notes handy, but I do recall the following studies regarding adults with PSC and vanco:
-multiple case reports on adults, including one involving a patient with rPSC that normalized on vanco.
-initial Mayo study looking at vanco or metronidazole. There was a follow-up report on these patients a few years later that found that those that had been treated with vanco, even temporarily, were significantly less likely to have reached end points.
-study from Tehran University in Iran.
-Stanford study looking at both pediatrics and adults (Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects - Study Results - ClinicalTrials.gov).
-current Mayo trial.

If you are interested I can get you or your team in touch with my hepatologist at the Georgetown Transplant Institute who has extensive experience treating PSC patients with OV. @Cactusgirl is also a wonderful reference for all things regarding the treatment and has worked extensively with a number of doctors on the topic.

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thank jtb. Great information.

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Hi Mark, I would stay on a higher dose (=>1500mg/day) until you have normal liver chemistries for at least a year. Then I would reduce by only 250mg and take labs monthly to make sure they are normal and stable before reducing by another 250mg, and so on. If you do not normalize at 1500mg, I would increase to 2000mg/day. Stanford increased some patients to 3000mg/day to achieve normalization. PM me if you want more information or to discuss.

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Thanks for all the replies. Very helpful. My insurance as it stands only covers the available generic at my pharmacy. Does it really make such a difference that I need to use a specific brand or should I just go ahead and see what the generic version I can get through insurance does fit me?

Mark

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Hi Mark! I’m really sorry to hear the bad news! I’ve used vanco for 3,5 years and have only used generic variants (and I don’t even have an insurance). The only issue people have is with the generic pills. If you get a prescription for liquid vanco, then you’ll be fine with generic variants. The only drawback is that it’s slightly less convenient to handle the liquid than take pills. Even without insurance, generic liquid vanco is roughly $230/month for 500mg/day, $460/month for 1000mg/day and $690/month for 1500mg/day.

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Andreas,
Why are pills a problem? I really don’t need any more dental issues and I keep hearing issues with oral vanco and dental problems. What is it about the pills that pose an issue. Thanks.

Mark

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Preliminary research suggests this may be an issue with the gel caps. When tested, the gel caps between brands had different rates of dissolution at certain pH (read: some patients). While slower dissolving gel caps do not appear to be an issue for those treating C. diff infections, this may be responsible for the decreased efficacy of certain brands of pill form vancomycin for a subset of patients attempting to treat their PSC.

The takeaway is that some patients have poorer results with many of the pill generics (Alvogen, Akorn, Lupin) compared with the Ani generic or compounded IV vanco. If you fill one of these generics and normalize in a couple months then there is nothing to worry about and no need to make changes. If LFTs remain elevated or if symptoms persist, it may be worth looking into either opening the pills before swallowing or working with your pharmacy to special order the Ani generic pills.

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A cautionary note. If your prescribing Doctor(s) are well tuned into and supportive of use of Vanco for PSC then go ahead with any generic you get covered, hedge by opening the pill if thats the form you get, and odds are that generic is most likely to be one that works (bioequivalent) and you will likely show fast declines in LFT’s. But if you’ve had to convince the Doctors - and they are hesitant/reticent about prescribing Vanco, you might consider the long term benefit to you of ensuring you WOW them with cause and effect by buying out of pocket of a known working brand in the first few months only. And then go on the covered stuff. Just an idea. If you’ve got a reluctant Dr who doesn’t understand the brand difference issue, you don’t want them to say ‘hey we tried it for 3 months and it didn’t work, not doing that again’. Again, the odds of getting a non working generic are low-ish but they’ve happened to posters here. For me, I was so desperate to find out if Vanco was going to save me from the return to the suffering, that I personally would have wanted to use a known product to get peace as soon as possible (but the expense forced me to get insurance-covered IV powder and luckily it worked fine). Again, just a thought, most important thing is you get on the stuff. The teeth staining doesn’t seem to happen to everybody, noone knows why, but just an inconvenience possibly minimized by a straw or some way to get it to not contact your teeth (I wrap my powder dose in rice paper and swallow like a pill). Hope to welcome you to the growing club of recovered rPSC’ers.

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BTW the teeth staining is a surface effect, it can be cleaned off at the dentist. So its got to be some chemical or bio reaction with saliva (its not like some drugs like tetracycline that can discolour your teeth permanently). I had a dental cleaning once to get rid of the slight tinge of brown guck, then opted for the rice paper since.

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So just to recap before I write my doctor again, is it the suggestion of asking for 500 mg to be prescribed 3 times a day to start off with, then as numbers normalize to back down to how much a day? I think I’ll start with the pill form. Thanks.

Mark

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Hi Mark! JTB had a great explanation for the pills. The liquid vanco causes staining of the teeth, but it’s just cosmetic. It doesn’t cause tooth decay. In the beginning, I brushed my teeth with a normal (manual) tooth brush, but later on I bought one of the more expensive electric tooth brushes and brushed my teeth 3 minutes instead of 2 minutes. After this, I no longer have any issues with my teeth.

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I’m going a bit from memory of what I gleaned from Dr. Ken Cox experience when I started on Vanco in 2014, but I recall the best ‘protocol’ at the moment (for most PSCers) is as you stated, 1500 mg/day (500 mg three times a day), then after a full year - wean down to 1000 mg per day same three times. Then after 6 mths or another full year at the 1000, wean down to 500/day. 500/day is where I’m at (250mg 2 times day). Check LFTs with each weaning and go back up if there’s an uptick. If the 1500 mg per day initial stage doesn’t move your LFT’s, some have gone still higher or change brand. The eventual weened down maintenance dose has also gone lower for some (to 250 per day). I am tempted to try since I was very very nacent rPSC (no damage) but I know from experience I won’t see an LFT uptik (feedback that it was insufficient dose) for over 2 years. So I’m staying conservative at 500/day. Weaning experience will vary for some (we are mostly guessing on this, and helping each other).

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Thanks, RJM That was exactly what I was needing. I actually pasted your response in the message to my transplant hepatologist.

Mark

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happy to help where I can sir. Thanks for all the help you’ve been to us as moderator for the site!

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I don’t want to take the focus off Mark but this thread is very synchronistic and I do want to interject with a concern I have right now on the same topic.

I’ve been taking Vancomycin - either ANI or FirVanq mattering what year and month my insurance would partially cover ANI - for four years.

Only twice in these four years have my liver enzymes normalized.

I’ve also continued to feel relatively terrible 24/7/365.

I’ve stayed on Vanco with the hope over time it would click in and also because taking it significantly healed my ulcerative colitis.

Reading this thread I’m wondering if I went high enough dosing Vanco.

Although I have gotten doctor Lindor’s feedback here and there, as a friend I cultivated through correspondence and not as my doctor, I’ve done all of this alone, with no help from doctors.

I’ve never gone higher than 1,500 mg daily. I am now on a maintenance dose of 250 mg 3x a day.

What has changed is after endless refusals from my pharma insurance company and endless appeals from my doctors to get it to be covered; I’ve found a “Speciality Pharmacy Liaison” who has miraculously been the first medical person to get Humana to cover Vanco almost fully at $75. a month as opposed to $1,200. (and as we know, ANI is like $70,000 annually entirely out of pocket for a moderate monthly dose). My cost now for FirVanq would be $35. a month instead of $400. if I could source it.

So, I can finally afford to raise my dose.

Question being, after four years and “stabilizing” on my very low Vanco dose, should I ask my doctor to write a prescription to raise it to the Cox/Stanford protocol of 3,000 mg a day and see what happens?

What could it hurt?

It does seem like Vanco partially has worked for me and I have no words to express how truly lovely it would be to stop feeling terribly sick day in and day out year after year decade after decade. As we all know, this is so difficult.

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of course advise there gets into Doctor stuff. I think many many have done the 1500 and wean down, but fewer for sure with the 3000 and I would say if your tapped into Dr. Lindor he’s one of the real experts to ask. I remember (I think) Dr. Cox mentioning the 3000 per day, as needed for a few patients who didn’t respond at 1500, in either the recent video from Cactusgirl or a 2018 one from JTB [Dr Ken Cox, Standford Health Care-Treatment of Pediatric PSC with Oral Vancomycin 9/30/2018 ]. Thats a starting point, I don’t remember where else in the literature or expert testimony that it is discussed.